Paranoia in People With Schizophrenia-spectrum Diagnosis Clinical Trial
Official title:
Computerised Interventions for Thinking and Anxiety in Delusions (CITADEL) Trial
People with a schizophrenia spectrum diagnosis often experience distressing worries or
beliefs about others intending to cause them harm (also known as paranoia). Paranoid beliefs
are associated with significant distress and disruption to the person's life. This results
in high use of services and costs to mental health providers.
The National Institute of Clinical Excellence recommends that cognitive behavioural therapy
for psychosis (CBTp) is offered to everybody with a schizophrenia spectrum psychosis. The
latest meta analyses report improved outcomes, and reduced inpatient stays following CBTp,
making it a cost effective intervention.
Although improved outcomes have been obtained by therapies, CBTp has only small to moderate
effects on paranoid beliefs. Further, training therapists to competently deliver CBTp is
intensive, expensive and takes up to a year. CBTp is therefore not widely available to
service users, resulting in inequalities in access to care.
The investigators are seeking to improve outcomes and accessibility of CBTp for people with
distressing, paranoid beliefs. The proposed research programme aims to conduct a feasibility
study of a brief therapeutic intervention, aimed at targeting and improving anxiety
processes that are causally implicated in paranoia (Freeman et al, 2015).
The investigators have preliminary evidence indicating that the pilot intervention, with
interactive multimedia content, reduced distressing beliefs and improved coping (Freeman et
al, 2015). Participants also reported they found the therapy acceptable, enjoyable and
useful. Based on these results, the investigators have further modified the intervention.
The feasibility and efficacy of the therapy will be investigated in a randomised controlled
design (n = 34).
Please note the protocol has been been amended to exclude a pilot trial of a second brief
intervention targeting reasoning styles in paranoia, as since the initial protocol was
developed we have obtained data from two randomised pilot studies demonstrating its
feasibility and acceptability (Garety et al, 2015; Waller et al, 2015). A further pilot
trial of the reasoning styles intervention is therefore not indicated.
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